SITUATION OF HEPATITIS B, C SURVEILLANCE IN THAI BINH AND EFFECTIVENESS OF SOME INTERVENTION

MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEALTH NATIONAL INSTITUTE OF HYGIENE AND EPIDEMIOLOGY ------------*-------------- VU NGOC LONG SITUATION OF HEPATITIS B, C SURVEILLANCE IN THAI BINH AND EFFECTIVENESS OF SOME INTERVENTION Specialty: Epidemiology Code: 62 72 01 17 PHD. THESIS SUMMARY HA NOI 2017

The Thesis was finised at NATIONAL INSTITUTE OF HYGIENE AND EPIDEMIOLOGY ------------*-------------- Ful name of scientific instructors: 1. Assoc. Prof. PHAN TRONG LAN, PHD. 2. Prof. PHAM NGOC ĐINH, PHD. Judge 1: Assoc. Prof. Doan Huy Hau, PHD. - Viet Nam Military Medical Academy Judge 2: Assoc. Prof. Trinh Thi Ngoc, PHD. - Bach Mai Hospital Judge 3: Assoc. Prof. Hoang Duc Hanh, PHD. - Department of Health of Ha Noi The Thesis will be defended before Thesis Assessment Council at Institute Level, in National Institute of Hygiene and Epidemiology at... dated... Be able to search the Thesis at: 1. The National Library 2. National Institute of Hygiene and Epidemiology Library HÀ NỘI 2017

LIST OF ABBREVIATION Abbreviation AIDS Anti-HCV ARN-HCV BVĐK CSHQ ĐNCB HBsAg HBV HCV HQCT MMT MOH NVYT PKB SCT TCT TTYT TYT VGVR VSDT WHO YTDP English Aquired Immuno Deficiency Syndrom Antibody against hepatitis C virus Acid Ribonucleic Hepatitis C virus General Hospital Effective Indicator Case Definition Hepatitis B surface antigen Hepatitis B Virus Hepatitis C Virus Effectiveness of Intervention Methadone Maintenance Therapy Ministry of Health Health care staff Outpatient Department After Intervention Before Intervention Health Center Commune Health Station Viral Hepatitis Hygiene and Epidemiology World Health Organization Preventive Medicine

1 RATIONALE Hepatitis B, C are major burdens for people s health, eventually leading to chronic liver disease, cirrhosis and liver cancer. Viet Nam has a high incidence of hepatitis B, C. In 2015, viral hepatitis was one of the notifiable diseases according to Circular 48/2010/TT-BYT of the Ministry of Health; however, due to the lack of classification of kinds of hepatitis vírus and the long time required for reporting, it was difficult to know the status of viral hepatitis for the timely implementation of a disease response in the community. In order to enhance the surveillance quality of hepatitis B, C, we conducted the study Situation of surveillance system of hepatitis B, C in Thai Binh and effectiveness of some interventions. Research Objectives: 1. Describe the situation of the surveillance system for hepatitis B, C in Thai Binh in 2015. 2. Evaluation of some intervention to enhance the quality of the surveillance system of hepatitis B, C at the district level in Thai Binh in 2016. NEW CONTRIBUTION OF THE THESIS This Thesis offers some new contributions, showing that implementation of screening testing for hepatitis B, C in Methadone Treatment Units in District Health Centers for drug users was an important information source of high risk group in hepatitis B, C surveillance system; intervention activities had provided scientific evidence about the changing ability of new hepatitis B, C surveillance approach from an integrated report with only the number of cases and number of deaths to produce case reports and reduce the reporting time. The quality of hepatitis B, C surveillance data at the district level had been improved with great usefulness; enhanced capability of health care staff on hepatitis B, C surveillance; fit with the mission, function and ability of health care staff; and high appreciation of sustainable maintainance of the intervention activities. From the results of the Thesis, we recommended to apply and expand implementation of surveillance based on case reporting and reducing time of report for hepatitis B, C; identify to include results of screening testing from high risk groups into surveillance system for hepatitis B, C to improve the sensitivity level

2 and quality of surveillance system; more investment in organizing training courses about hepatitis B, C surveillance for health care staffs working in diagnosing, treatment, testing, reporting in communicable disease surveillance system in order to improve suistainably the capacity of implementing hepatitis B, C surveillance activities in district level. STRUCTURE OF THE THESIS The Thesis includes 127 pages, 4 chapter: Rationale: 2 pages, Chapter 1 Background - 38 pages, Chapter 2 Research Methodology - 23 pages, Chapter 3 Results - 35 pages, Chapter 4 Discussion - 25 pages, Conclusion - 2 pages, Recommendation - 1 page. The Thesis has 33 tables, 8 figures, 4 charts, 131 national and international reference documents. CHAPTER I. BACKGROUND 1.1. General information on viral hepatitis Viral hepatitis is common name for all kind of liver diseases caused by virus, majority of hepatitis virus are hepatitis A, B, C, D, E, G. Yearly, there are around 1,000,000 deaths related to viral hepatitis diseases. There was estimation of 57% cirrhosis of the liver and 78% liver cancer due to primary infection of hepatitis B, C virus. 1.2. Status of infection hepatitis B, C in the world and Viet Nam 1.2.1. Infection of hepatitis B virus 1.2.1.1. Status of infection hepatitis B in the world Hepatitis B is a global issue. There are 2 billions people infected hepatitis B virus, of which 180-240 millions people got chronic hepatitis B, Asia contrubuted for 3/4 of the chronic hepatitis B in the world. 1.2.1.2. Status of infection hepatitis B in Viet Nam Viet Nam is in high endemic region of hepatitis B, C. According to estimation of WHO, in Viet Nam in 2015 there were about 8.4 million people exposuring to chronic hepatitis B. In some region of Viet Nam, rate of people positive with HBsAg was around 15-20%.

3 1.2.2. Infection of hepatitis C virus 1.2.2.1. 1.2.1.2. Status of infection hepatitis C in the world Hepatitis C is still popular in many countries, WHO estimated that there are 130-170 millions infected to hepatitis C virus and yearly around 3-4 millions people infected to hepatitis C virus. 1.2.2.2. Status of infection hepatitis C in Viet Nam Viet Nam is also high endemic country of hepatitis C, some research found that infection of hepatitis C virus in community is around 1.4 to 4.1% of population. This rate of hepatitis C virus infection in high risk group was around 70.5% in blood transfusion people, and in drug injection people, it was up to 31% in Ha Noi and 87-97% in Ho Chi Minh City. 1.3. Surveillance for communicable diseases and viral hepatitis 1.3.1. Surveillance for communicable diseases Surveillance is process of ongoing systematic collection, collation, analysis and interpretation of data and the dissemination of information to evaluate and response when necessary. 1.3.2. Surveillance for viral hepatitis 1.3.2.1. Surveillance for viral hepatitis in the world Currently, communicable disease surveilance system in developed countries often leaded by one organization responsible for implementation of different models such as separate surveillance systems for some specific disease group in United State, Europe, Asia,... viral hepatitis surveillance system also was considerable, mostly focusing on hepatitis B, C. 1.3.2.2. Surveillance for viral hepatitis in Viet Nam Following to Circular Number 48/20010/TT-BYT dated 31/12/2010 of the Ministry of Health, procedure of reporting of communicable diseases was implemented from grass root level to central level, including: commune level, district level, provincial level, regional level and central level. Reporting data included: number of case/ number of death, distributed by province, region, and month of the year, integrated data not by kind of hepatitis virus and case base reporting.

4 - Objective obstacles: there are many kinds of hepatitis virus, unclear symptom, blur in acute period, long acubation period, most of cases consequenced to chronic disease, many different transmision. - Subjective weakness: no official guideline for viral hepatitis, mostly identifided by clinical syptoms, unclassified kind of hepatitis virus, no sentinel surveillance for viral hepatitis, low awareness of health care staff in hepatitis surveillance. 1.4. Strategic on hepatitis prevention and control in the world and in Viet Nam 1.4.1. Some strategic on hepatitis prevention and control in the world The WHO has considered date 28 July as the World Hepatitis day and the first celebration was in 2011. In 2012, the WHO had issued the Framework for Global Action on Prevention and Control of Viral Hepatitis Infection with the vision of stopping viral hepatitis transmision in the world and all people having access to safe and effective care and treatment. - In United States: the Action Plan with the aim at reducing viral hepatitis transmission and morbidity/mortality of hepatitis B, C. - In Europe: strategic frame work for all responding activities to viral hepatitis including hepatitis B, C. - In Mongolia: National Strategic against viral hepatitis approved in 2010 with overall objective Reduce morbidity of viral hepatitis to 10/10.000 population in 2015. - In Japan: all strategy and activities on prevention and control of viral hepatitis focused on community approach. 1.4.2. National Plan on hepatitis prevention and control in Viet Nam In 2015, the Ministry of Health issued National Action Plan on Viral Hepatitis prevention and Control period 2015-2019 with aim at Reduce transmission of viral hepatitis and increase access of people to health care facilities for prevention, diagnostic, care and treatment of viral hepatitis. Of which, it was paid attention on prevention of transmission of hepatitis B, C, improving capacity of surveillance system and information

5 collection to provide scientific evidence for development of policies and intervention on reduce transmission of viral hepatitis in community and health care facilities. CHAPTER II. RESEARCH METHODOLOGY 2.1. Objective 1: Describe situation of surveillance system for hepatitis B, C in Thai Binh in 2015 2.1.1. Research target - Research units: health care institutions at provincial, district, and commune levels, including private hospital participated in hepatitis B, C surveillance. - Health care staffs involving to hepatitis B, C surveillance activities in the research units. - Profile: working reports, documents about human resource, activity results related to surveillance, tesing, treatment for communicable diseases, viral hepatitis. 2.1.2. Time and place of the research In December 2015, in Thai Binh 2.1.3. Research methodology 2.1.3.1. Research method Cross-sectional descriptive study including qualitative, quantitative and reviewing secondary data in order to describe situation of hepatitis B, C surveillance in provincial, district, and commune levels in Thai Binh. 2.1.3.2.Sample size Use sample size formular for a rate estimation: 2 p(1 p) n = Z α 1. DE 2 d 2 Of which: p: rate of health care staff having correct knowledge on diagnotis, testing, and surveillnace for hepatitis, sellected p = 0.5; Z 1 - : confidence level, with confidence level 95% Z 1 - = 1.96; 2 2

6 d: expected accuracy (d = 0.08); n: estimated number of health care staff for interview; DE: design effect, used DE= 2. Based on this formular, sample size estimation was 300 health care staffs. Infact, we had collected 370 health care staffs eligible for this research. 2.1.4. Information collection tool - Collection form for available data from: Department of Health, Hospital, Preventive Medicine Center, Commune Health Station. - Designed questionair for interviewing health care staff and deeply interviewing leader of health unit related to communicable disease surveillance. 2.1.5. Steps of reseach implementation: Develope proposal and interview form, organize training for interviewers and supervisor; pilot the data collection form; collect information. 2.2. Objective 2: Evaluation of some intervention activities to enhance quality of hepatitis B, C surveillance at district level in Thai Binh in 2016. 2.2.1. Research target: all health care staffs working tin departments related to hepatitis B, C surveillance in District Health Center and District Hospital in a case district and a control district. 2.2.2. Time and Place for the research From January to December 2016 in Hung Ha (case district) and in Vu Thu (control district).

2.2.3. Research Methodology 7 2.2.3.1. Research method: A case-control interventional study with pre and post interventional evaluation to assess the intervention effectiveness. 2.2.3.2. Sample size and sampling Applied convenient method, sellect all health care staffs working on hepatitis B, C surveillance in case district and control district. 2.2.4. Information collection tool and intervention activities 2.2.4.1 Information collection tool - Designed questionair to interview health care staffs - Case report form for confirmed cases of heaptitis B, C in Hung Ha district. 2.2.4.2. Some intervention activities * Activities in the case district during conducting research: - Training to improve knowledge, attitude, practice of health care staff on hepatitis B, C in diagnotis, testing, surveillance, report, including: + Health care staff in outpatient department, communicable disease inpatient department on diagnotis, care and treatment (following to guidance of MOH/ WHO). + Health care staff in bio/imunity-laboratory of district hospital, district health center on testing method for diagnosis of hepatitis B, C (following training documents of NIHE in 2015). + Health care staff working on hepatitis B, C surveillance in case district on new approach of hepatitis B, C surveillacne through case base reporting. - Change approach of hepatitis B, C surveillacne, including: + Case based report for hepatitis B, C patient with basic epidemiology information and testing results to facilitate following up new patient, supporting for treatment, prevention activities. + Applied case definition for hepatitis B, C. + Use case report form: including basic epidemiology information of patient and testing results.

8 + Time for reporting: within 48 hours from identified confirmed case. + Reporting unit: district hospital responsible for reporting to surveillance system, district health center responsible for monitoring, synthetysing and proposing responding and prevention activities in community. + Reporting method: email * Activities in the control district during conducting research: For the control district, the viral hepatitis surveillance was still following existing guidance of the Ministry of Health with procedure and report form of the Circular 48/2010/TT-BYT. 2.2.5. Step of research implementation: Completed all proposal intervention activities; conduct training courses to update knowledge, improve attitute and practice of the staffs working on hepatitis B, C surveillance in case district; applied new approach for hepatitis B, C surveillance in case district for 12 months; analysed the results. 2.3. Data entry and analysis 2.3.1. Used software Data was cleaned before entried; Coding and entrying in computer based on EPIDATA 3.1 software with file check to control data error during entry. Analysing and displaying data based on STATA 12 software. 2.3.2. Method for analysing and displaying result of intervention - Effectiveness indicator (CSHQ) of intervention activites: comparte pre and post results: Based on comparision method for 2 rates, use Chi-squared and p-value, estimation of percentage of improvement by formular: Of which: CSHQ (%) = p1 p2 x 100 o p1 is percentage of research indicator before intervention. o p2 is percentage of research indicator after intervention. p1

9 - Interventional effectiveness (HQCT) was compared effectiveness indicator between case and control district: HQCT = CSHQ (case) CSHQ(control) + Estimation of sensitivity: calculated by number of confirmed case of hepatitis B, C reported over total estimated hepatitis B, C patient among people accessing to district hospital for examination. Estimation of hepatitis B, C patient among people accessing to district hospital for examination was calculated by: n=r.m.b Of which: n: number of hepatitis B, C patient among people accessing to district hospital for examination r: estimation rate of HBV, HCV infection among people accessing to district hospital for examination m: estimation rate of hepatitis B, C patients among people infected to HBV, HCV among people accessing to district hospital for examination. B: number of people accessing to district hospital for examination 2.4. Organizing of implementation The General Department of Preventive Medicine and National Institute of Hygiene and Epidemiology (training institute) collaborated to the National Hospital of Tropical Disease, Department of Health of Thai Binh, Thai Binh Preventive Medicine Center, Thai Binh General Hospital, District Health Center to implement all activities of the research. 2.5. Ethical issue of the research The research proposal was approved by Ethical and Scientific Board of the National Institute of Hygiene and Epidemiology before implementation.

10 CHAPTER 3. RESULTS 3.1. Situation of hepatitis B, C surveillance system in Thai Binh in 2015 3.1.1. Situation on structure, component and legislation of hepatitis B, C surveillance In the overal context in Viet Nam, hepatitis B, C surveillance in Thai Binh was integrated to other communicable diseases regulated by the Circular No. 48 /2010/TT-BYT of the MOH. Participants in hepatitis B, C surveillance included hosptitals, preventive medicine centers in provincial, district, and commune levels including private hospital. In Thai Binh, the Methadone Maintenance Therapy (MMT) had been implementing from end of 2014 for drug users; up to 2015, there were 8/8 District Health Center and Provincial AIDS Center implemented MTM. The drug user was high risk group of HCV infection. According to the Dicision No. 493/QĐ-BYT dated 18/02/2016 of the MOH on guidance for MTM, from 2016, all MTM Centers in Thai Binh applied screening of HBV, HCV for all drug users. All the cases infected to HBV, HCV identified from provincial AIDS Center and District Health Center had been transfered to hospitals for treatment. Table 3.2. Number of Methadone treatment patient in 2015-2016 Number of patient 2015 2016 Compared (%) Center for AIDS Control 260 211-18,9 Thai Binh town Health Center 312 275-11,8 Kien Xuong District Health Center 102 85-16,7 Dong Hung District Health Center 157 143-8,9 Vu Thu District Health Center 131 110-16,0 Quynh Phu District Health Center 205 187-8,8 Tien Hai District Health Center 201 181-9,9 Thai Thuy District Health Center 171 148-13,5 Hung Ha District Health Center 106 141 + 33,0 All Thai Binh province 1.645 1.481-10,0

11 3.1.2. Situation of capacity assurance, policy, benefit for health care staff in hepatitis B, C surveillance systems 3.1.2.1. Situation of equipment for viral hepatitis surveillance Currently, equipments for informing, reporting of data of communicable disease surveillance in all institutios of province, district, and commune level of Thai Binh were provided enough to serve for communicable disease surveillance activities, including viral hepatitis. A leader of Provincial Health Department: Based on some Projects, most of the health units from provincial, district, and commune level of Thai Binh had been equipted for reporting of communicable diseases. 3.1.2.2. Situation of bio-laboratory for hepatitis B, C surveillance Among bio-laboratories participated in testing HBV, HCV, 100% of them were able to conduct rapid test of HBsAg. For Anti HCV rapid test, most of the bio-laboratories were conductable; however, in district hospitals, there were only 50% of hospitals being able to do. Provincial General Hospital and Provincial Preventive Medicine Center were able to conduct most of testing for confirming HBV, HCV, while District Health Centers could conduct testing least. No bio-laboratrory could conduct testing for sequencing of HCV. No commune health station was able to test for hepatitis B, C. 3.1.2.3. Situation of report form being used for communicable disease surveillance In 2015, hepatitis reports in Thai Binh province were following to the Circular 48/2010/TT-BYT of the Ministry of Health, there were only two types of reports: monthly and yearly report, no weekly report; the Circular did not request for separating report of hepatitis B and hepatitis C, it was integrated in viral hepatitis report. Sudden report during outbreak was requested; however, in practice, it was not used yet any time. Additionally, case definition for hepatitic B, C were not applied in health care units of Thai Binh province.

12 3.1.2.4. Situation of implementation of collaboration and coordination mechanism in viral hepatitis surveillance Collaboration and coordination mechanism in communicable disease surveillance, including viral hepatitis surveillance, had been considered and directed by the Department of Health of Thai Binh to all health care facilities, including private hospitals to report to Provincial Preventive Medicine Center and District Health Centers through official documents as well as direction in the yearly kick off meeting for annual medicine action plan. Most of the investigated health units reported that collaboration between preventive and curative sectors was in medium and high level, of which medium level was 56,2%. In commune level, there was only one health station, no separation of curative and preventive sector. 3.1.3. Situation of implementation capacity of hepatitis B, C surveillance system in Thai Binh in 2015 3.1.3.1. Reeport with testing result of hepatitis B, C in 2015 Hospitals had information and results of hepatitis B, C testing, however, following Circular No. 48/2010/TT-BYT, there was no request for reporting results of HBV, HCV testing, therefore Provincial Preventive Medicine Center and District Health Centers did not collect and report. In Health Station at commune level, there was no capacity for hepatitis testing, therefore they did not include hepatitis B, C in monthly report. 3.1.3.2. Use of results of hepatitis B, C surveillance on developing action plan on prevention and control of communicable diseases Results of hepatitis B, C surveillance were used quite a little for prevention and control communicable diseases, except in some hospitals. No any health care unit often used the result of hepatitis B, C surveillance on developing action plan on prevention and control of hepatitis B, C. 3.1.4. Result of survey on knowledge, attitude, and practice on activities of viral hepatitis surveillance in Thai Binh in 2015 Rate of health care staffs having correct general knowledge about hepatitis virus was 61.8%. Rate of health care staffs at health station having correct knowledge was lower than health care staffs at provincial level, 52.3% and 73.7% respectively.

13 Rate of health care staffs having correct attitude when responding to question related to viral hepatitis were quite good, range from 62.3% to 72.2% (in average 65.8%). In overall, health care staffs at all levels having correct attitude about applying prophylactic treatment for children at birth was highest with 69.2%; while having correct attitude about situation of infection of viral hepatitis in community was lowest with 61.1%. Overall correct practice of health care staffs working in hepatitis B, C surveillance was 59.1%; of which, health care staffs at provincial level was higher than other group, especially about practice in case report. 3.2. Evaluation of effectiveness of some intervention activities in enhencing quality of hepatitis B, C surveillace in Thai Binh in 2016 Hepatitis B, C surveillance had changed in Hung Ha in 2016. In 2015, all district of Thai Binh applied Circular 48/2010/TT-BYT of the Ministry of Health with monthly and yearly report for viral hepatitis. In 2016, Hung Ha applied case report within 48 hours including result of hepatitis B, C testing via email; Hung Ha district hospital directly report to the surveillance system, Hung Ha district health Center played role of synthetizing and analyzing the situation. In Vu Thu district, control district, still applied Circular 48/2010/TT- BYT for hepatitis surveillance as usual. 3.2.1. Results of identifying hepatitis B, C in 2016 Table 3.1. Number of hepatitis B, C patients identified in 2016 in Hung Ha and Vu Thu district Kinds of hepatitis viral Hung Ha Vu Thu Number % Number % HBV 180 70.0 138 78.9 HCV 73 28.3 35 20.0 Co-infection of HBV and HCV 4 1.7 2 1.1 Total 257 100.0 175 100.0 In 2016, Hung Ha district reported 257 cases of hepatitis B, C, of which infection of HBV was 70.0 %, HCV was 28.3 %, there was 1.7% of patients co-infected of HBV and HCV. Vu Thu district reported 175 case of hepatitis B, C with infection rate of HBV, HCV and co-infection of HBV, HCV were 78.9%, 20.0% and 1.1%, respectively.

14 Bảng 3.2. Situation of viral hepatitis infection in groups of MTM in Hung Ha and Vu Thu in 2016 Group of Methadone Treatment Method Hung Ha (n=141) Vu Thu (n=110) Infection status of viral hepatitis Number % Number % HBV 17 12.1 13 11.8 HCV 64 45.4 47 42.7 Co-infection of HBV and HCV 4 2.8 2 1.8 No infected 56 39.7 48 43.6 Rate of HBV, HCV infection among total hepatitis B, C patients of the district 85/257 33.3 62/175 35.4 Among MTM patients, rate of HBV, HCV infection in Hung Ha and Vu Thu were 45.4% and 42.7%, respectively. It was high rate of HBV, HCV infection compared to all hepatitis B, C identified in the districts with 33.3% in Hung Ha and 35.4% in Vu Thu. 3.2.2. Effectiveness in changing quality of hepatitis surveillance Table 3.3. Effectiveness of quality of hepatitis B, C report Content of assessment TCT (1) (%) Hung Ha SCT (2) CS (%) HQ TCT (3) P (1,2) (%) Vu Thu SCT (4) (%) CS HQ P (3,4) HQCT p SCT (2,4) (n=170) (n=257) (%) (n=173) (n=175) (%) Data quality Completeness rate of the data reported Rate of report with pathogen testing results in report of hospitals Timeliness Rate of report to surveillance system in time 91.8 81.7 - - 90.8 94.9 - - - 22.7 75.3 97.3 29.2 <0.001 75.7 80.6 6.5 >0.05 <0.0001 74.7 50.6 - - 75.1 83.3 - - -

Usefulness Use of surveillance results in prevention and control for hepatitis B, C TCT: Before intervention CSHQ: Effectiveness indicator (n=65) (n=67) 15 (n=66) (n=69) 30.,7 50.7 65.1 <0.05 31.8 36.2 13.8 >0.05 SCT: After intervention HQCT: Intervention Effectiveness 51.3 <0.05 Report with pathogen testing results in the report of hospital was improved with CSHQ=29.2%. Use of surveillance results in prevention and control for hepatitis B, C was also significantly improved in Hung Ha with CSHQ=65.1%, comparing between before and after intervention and between two district, Hung Ha had intervention effectiveness significantly high with 51.3%, p<0.05. 3.2.3. Effectiveness of sensitivity of intervention activities in Hung Ha Table 3.4. Estimated sensitivity of the intervention activities in Hung Ha in 2015 2016. Estimation rate of viral hepatitis infection (%) (*) In 2015 (Before intervention) Estimation rate of symptomatic patient of viral hepatitis (%) (**) Number of patient examined in district hospital (***) Estimation of symptomatic patient of viral hepatitis in district hospital (****) Number of hepatitis B, C identified Sensitivity of the interventio n Hepatitis B 10.8 20 65,229 1,409 128 9.1 Hepatitis C 1.2 20 65,229 157 42 26.8 In 2016 (After 1 year intervention) Total 1,566 170 10.8(1) Hepatitis B 10.8 20 68,560 1,481 184 (****) 12.4 Hepatitis C 1.2 20 68,560 165 73 44.2 Total 1,646 257 15.6 (2) p (1,2) <0.001 Effectiveness indicator for both Hepatitis B, C 44.4% Effectiveness indicator for Hepatitis B 36.3% Effectiveness indicator for Hepatitis C 57.5%

16 (*): Estimation of WHO for Viet Nam (**): Estimation of symptomatic patient of viral hepatitis in Viet Nam (***):Viral hepatitis report in Thai Binh in 2015, 2016 (****) including 4 co-infection case of hepatitis B, C In 2015, sensitivity of hepatitis B, C was 10,8, significantly lower than it in 2016 with 15.6, p<0,001. Effectiveness indicator for both hepatitis B, C in 2016 comapred to 2015 in Hung Ha was 44.4%. 3.2.4. Result of health care staff about usefulness and acceptability of the intervention in Hung Ha 3.2.4.1. Usefulness of the intervention for health care staff in Hung Ha Regarding to usefulness of the intervention for health care staff, 83.6% of them reported that it improved their own capacity for hepatitis B, C surveillance, and 85.1% reported about improving quality of hepatitis B, C surveillance activities. Regarding to suitability factor of the intervention, 92.5% of health care staff reported that it was suitable to their own working postions; 77.6% and 74.6% were suitable to their own capacity and professional training, respectively; while there were 67.2% of them reported about enough time to participating hepatitis B, C surveillance activities. 3.2.4.2. Result about application of the intervention in Hung Ha Results about application of the intervention in Hung Ha showed that 82.1% of the health care staffs considered case definition was easily applicable in hospital; 86.5% of the reports showed that report form was easily filled; 85.1-77.6% of the reports agreed with the reporting method, and 80.6% of the them considered the intervention activities could apply suistainably in the coming time. CHAPTER 4. DISCUSSION 4.1. About situation of hepatitis B, C surveillance in Thai Binh in 2015 Viral hepatitis surveillance in Viet Nam was following to the Circular No. 48/2010/TT-BYT dated 31/12/2010 of the Ministry of Health, it was

17 intedgrated to the national communicable disease surveillance and data report mostly based on clinical symptoms, no separating kinds of virus and not yet case based management. This regulation was not applicable for hepatitis B and hepatitis C because they had different prevention and treatment measures, therefore it was needed confirmed diagnosis for the most effectiveness of prevention and treatment. 4.1.2. About capacity assurance, policies in hepatitis B, C surveillance system in Thai Binh in 2015 4.1.2.1. Equipment for viral hepatitis surveillance Compared to other provinces, equipment and facilities for communicable disease surveillance, included viral hepatitis in Thai Binh were quite good at all levels from provincial to commune levels with availability of basic need equipment such as telephone, fax machine, computer, internet lines. However, this equipment was downward quality and needed maintenance. 4.1.2.2. Laboratory system for hepatitis surveillance At provincial health care facilities, including private hospital were able to conduct pathogen testing for both HBV and HCV; at district level, they were able to test for hepatitis B, C but limited in rapid tests for screening of suspected cases. Resultly, if the suspected cases of viral hepatitis B, C were screened in district hospitals, they could send samples to provincial level for confirmation. 4.1.2.3. About use of case definition in hepatitis B, C surveillance system The case definition of hepatitis B, C were not yet implemented in health care institutions in Thai Binh. In fact, up to 2015, the Ministry of Health just issued National guideline for diagnosis and treatment of hepatitis B, in 2016, issued Case definition of communicable diseases and National guideline for diagnosis and treatment of hepatitis C; however, dissemination through training courses was not reach to all health care staffs. 4.1.2.4. About collaboration, cooperation in hepatitis B, C surveilance Collaboration, cooperation in hepatitis B, C surveilance in Thai Binh had been directed by the Provincial Health Department of Thai Binh,

18 hospitals in provincial and district levels are also aware about their roles; however, in practice they did not fully follow up as regulation. * About use of surveillance data in developing action plan for prevention and control on communicable diseases In 2015, report of the surveillance mostly based on clinical symptom, not yet case management, no separation of HBV and HCV and not yet enough information to follow up hepatitis case in community. Therefore, in practice, it was quite a little used surveilance report in developing action plan for prevention and control on communicable diseases, except in some hospitals. 4.1.2.5. About knowledge, attitude, practice of the health care staff in hepatitis surveillance There were up to 83.9% of health care staff working in provincial level having correct knowledge on hepatitis virus; there were only 48.6% of health care staffs in commune level understood about necessary of hepatitis surveillance based on case management. Results of survey on attitude and practice of the health care staffs in overall of hepatitis surveillance, hepatitis B, C in particular, showed that health care staffs in provincial level had higher rate of correct attitude and practice than other groups. 4.2. About effectiveness of some interventions to enhance quality of hepatitis B, C surveillance in distrct level in Thai Binh in 2016 4.2.1. About identifying hepatitis B, C in 2016 Number of hepatitis B, C identified in Hung Ha in 2016 was higher than in 2015. Of which, there were many patients participated in Methadone treatment, contributed to 33.3% of all hepatitis B, C reported in Hung Ha and 35.4% in Vu Thu; thus, it was implied the important role of information source from screening testing of the high risk groups. 4.2.2. About effectiveness of changing quality of hepatitis B, C surveillance * For use of hepatitis B, C surveillance data of the health care staffs When applying new approach in hepatitis B, C surveillance as requested of the thesis, hepatitis B, C cases were reported immediately to

19 the surveillance system right after getting confirmation; in parallel each case report also included information of the patient and results of testing for hepatitis virus. These ensured quality of the data. In fact, there was different hepatitis B, C surveillance data quality between Hung Ha and Vu Thu, of which effectiveness indicator of sensitivity for hepatitis C was 57.5%, it was higher than its for hepatitis B with 36,3%. The change of the hepatitis B, C surveillance activities after intervention showed that rate of report in time with all information as requested in Hung Ha was not high due to changing of reporting mechanism for hepatitis B, C from report once per month to report within 48 hours righ after identifying confirmed case. The new approach for reporting was applicable with rate of more than 50% of report in time within 48 hours and more than 81% of report with full information as requested. It was needed to get systematic direction from higher level to all surveillance system. Rate of report with hepatitis B, C testing in surveillance from hospitals was improved with effectiveness indicator 29.2%. This was understandable with enhancing in awareness and practice of health care staffs in hepatitis B, C surveillance after interventions and their compliance in applying new approach for hepatitis B, C surveillance. * About increasing sensitivity of identifying hepatitis B, C in Hung Ha Results showed that sensitivity in identifying hepatitis B, C in Hung Ha in 2016 was higher than it in 2015, 15.6 and 10.8 respectively. This might be due to improvement of awreness of health care staffs in examination as well as testing for hepatitis B, C confirmation. Additionally, screening testing to identify HIV, HBV, HCV in MMT Unit in District Health Centers in Thai Binh implemented following to Decision No. 493/QĐ-BYT dated 18/02/2016 of the Ministry of Health for MTM guidance contributed for early detecting of HBV, HCV infection, especially HCV in high risk groups. 4.2.4. About acceptability and usefulness of the intervention in Hung Ha 4.2.4.1. Acceptability and usefulness of the intervention in Hung Ha Acceptability of the related institude in new approach for hepatitis B, C surveillance was key determinant for achievement as well as maintainance of the intervention in the future, the health care staffs in Hung Ha were aware about their benefit of the intervention not only in

20 improving their own capacity in hepatitis B, C surveillance (83.6%), but also enhancing hepatitis B, C surveillance activities (85.1%). Rate of health care staffs having enough time for surveillance was 67.2%, it was explainable because this was started new hepatitis B, C surveillance approach with new regulation requesting provision of many more information, reduce of time for reporting compared to previous requirement, therefore it might need more time for adaptation in the context of lack of human resource in hospitals. However, in balance of both usefulness and their effort for improvement of hepatitis B, C surveillance system, most of the health care staffs considered new approach for hepatitis B, C surveillance was suitable for their own as well as for their office. 4.2.4.2. About applicability of the intervention in Hung Ha Most of the health care staff considered that the case definition was easy to use, report forms were simple, reporting method was applicable, timeline was suitable with more than 82%, and 77.6% of them considered that surveillance activities was easy to do. It was important that up to 80.6% of the health care staffs agreed with following up the new surveillance approach after intervention. This was base line for expanding intervention to other districts in Thai Binh or in other provinces nationwide. CONCLUSION 1. Situation of hepatitis B, C surveillance system in Thai Binh in 2015 - Communicable disease surveillance, including hepatitis B, C, in Thai Binh had structure with all levels in province, components of the surveillance including curative, preventive and private sectors; however, hospitals were not active in reporting hepatitis B, C case to the surveillance system. - Implementation of Methadone Maintenance Therapy in District Health Center for drug users was important information source contributing to the surveillance system, in order to early detection of heaptitis B, C patient among high risk groups.

21 - Surveillance procedure of the Circular 48/2010/TT-BYT was not regulated separating hepatitis B, hepatitis C, there was no case definition for hepatitis B, C, and no specific guidance for hepatitis B, C. - Reports of hepatitis surveillance was quite a little used in developing action plan for prevention and control of communicable diseases due to simple data and not enough information (50% of health institution at provincial level, 31.2% at district level, and 16.7% at commune level). - Knowledge, attitude, and practice of health care staffs on hepatitis B, C surveillance in overal were still low, different at provincial, district and commune levels. It was lowest at commune level with rates of 68.1%, 65.8%, and 59.1%, respectively. 2. Effectiveness of some intervention to enhance quality of hepatitis B, C surveillance system in Hung Ha, Thai Binh in 2016 - Intervention activities had provided scientific evidence about ability of changing surveilance approach for viral hepatitis from integrated report (only number of case and death) to case report and shortened time for reporting. - Screening of hepatitis B virus, hepatitis C virus for drug users participating Methadone Maintenance Therapy in District Health Centers was important source of information for hepatitis B, C surveillance that contributed to 33,3% among total hepatitis B, C identified. - Quality of hepatitis B, C surveillance data in district level had been improved, intervention effectiveness for report with hepatitis B, C testing results was 22.7%; effectiveness indicator for sensitivity in case district was 44,4%. - Usefulness of the intervention was high, especially for use of surveillance data in developing action plan for communicable diseases prevention and control with 51.3%; intervention effectiveness for correct knowledge on case definition was 60.8%; intervention effectiveness for attitude related to consideration for situation of hepatitis B, C infection in community was 25.5%; intervention effectiveness for practice of checking information about kinds of hepatitis virus when receiving report was 35.4%.

22 - Intervention activities contributed to enhance capacity of health care staffs on hepatitis surveillance (83.6%), improve quality of hepatitis B, C surveillance activities (85.1%); suitable to function, position of health care staff (92.5%); suitable to capacity of health care staff (77.6%); suitable to professtional training of the health care staffs (74.6%). Stability of the intervention was quite high with 80.6% of respondants. RECOMMENDATION 1. The Ministry of Health should consider to apply and expand implementation of hepatitis B, C surveillance with case report, including clinical epidemiological information, testing result, reduce time for reporting after identifying case of hepatitis B, C, and enhancing role of hospitals in reporting of hepatitis B, C in communicable disease surveillance. 2. Preventive Medicine Institutions which are focal point of communicable diseases at provincial and district levels should pay attention on identifying information source from screening testing of high risk group such as Methadone Maintenance Therapy patients or other high risk groups to early identify hepatitis B, C patients for conselling, treatment, and reporting to hepatitis B, C surveillance system in order to increase sensitivity and quality of the surveillance. 3. Provincial Health Department should consider investing resource for conducting training courses on hepatitis B, C surveillance for health care staffs working in diagnosis, treatment, testing, reporting in the communicable disease surveillance system in the province to stably enhance hepatitis B, C surveillance capacity of the health care staffs as well as hepatitis B, C surveillance activities in district level.

23 LIST OF RELATED MANUSCRIPTS 1. Vu Ngoc Long, Tran Dac Phu, Tran Van Ban, Pham Thi Duyen, Nguyen Van Thom, Nguyen Huu Thang, Pham Bich Ngoc, Phan Trong Lan, Pham Ngoc Dinh, Knowledge, attitude and practice of medical officers involving to surveillance of hepatitis B and hepatitis C in thai binh, 2015, Journal of Preventive Medicine, Chapter XXVI, No. 13, 2016, pp 60-68. 2. Vu Ngoc Long, Pham Ngoc Thanh, Nguyen Van Thom, Phan Trong Lan, Pham Ngoc Dinh, Situation status of key issues involving to surveillance of hepatitis B and hepatitis C in thai binh, 2015, Journal of Medicine of Viet Nam, Chapter 453, 2017, pp 128-135. 3. Vu Ngoc Long, Tran Dac Phu, Nguyen Van Thom, Do Van Suu, Luong Van Phong, Pham Thi Duyen, Phan Trong Lan, Pham Ngoc Dinh, Effectiveness of intervention in enhencing quality of surveillance of hepatitis B, C in Thai Binh, 2016, Accepted to be published in Journal of Preventive Medicine, Chapter XXVII, No. 9, 2017, pp...